Spreadsheets such as Excel, are available for creating a wide range of end user applications, including widespread use in the laboratory, creating customized statistical analyses, the creation of local databases, data mining, and multivariate analysis. These may be used for GxP regulated activities, and they present particular compliance challenges, as Excel and other spreadsheets are not originally designed for the regulated environment.

GxP records generated by spreadsheet calculations are electronic records and should comply with FDA’s 21 CFR Part 11 and the European Annex 11. For critical records Part 11 controls, such as data accuracy and data integrity, should be implemented. Currently there are no specific industry FDA guidelines on using spreadsheets in regulated environments. However, the flexibility and power of the spreadsheet allows users to create tools that range from performing simple calculations to sophisticated analysis of a major clinical study, or laboratory or manufacturing data.

This makes spreadsheets a very powerful and useful tool in the GxP environment especially when coupled with the fact that it is easy to build spreadsheet applications without much training. However, this has resulted in spreadsheets being among the most under-documented systems used in GxP environments because:

• users regard them as part of the desktop
• the ease with which applications can be built without much training
• the data processing power that they can have
• lack of knowledge that spreadsheets need to be validated
• lack of knowledge on how to validate spreadsheets

Consequently, Spreadsheets have become “low hanging fruit” during FDA or other regulatory inspections and many warning letters have been issued.

Areas Covered

Part 11 / Annex 11 Computer Systems Validation (CSV) is be implemented in order to increase the integrity, accountability and security of the spreadsheets and achieve GxP Compliance. CSV enables the level and rigor of specification and verification applied to spreadsheets to be based on spreadsheet risk, complexity, and novelty. This hands-on seminar will provide the attendees with the tools for successful computer systems validation for Excel Spreadsheets. It will address the following topics: